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Emergency Use Authorizations for Medical Devices
… Zika Virus Molecular Emergency Use Authorization (EUA) Assays – Performance Evaluation and Key Characteristics: … detection of RNA from Zika virus in human serum and EDTA plasma from individuals meeting Centers for Disease … detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched …
Fast Masks USA LLC - 612088 - 03/26/2021
… For kids and adults o Accuracy: 98.5% o FDA Authorized and EUA Approved… What are At-Home Coronavirus Test Kits? . . . … to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, or sodium citrate), and venipuncture whole blood (heparin, dipotassium EDTA, or sodium citrate).However, this EUA does not authorize …
USH Diagnostics, Inc./covidinstanttest.net - 612084 - 07/09/2021
… and meeting other mandatory testing requirements FDA EUA AUTHORIZED LOWER NASAL COVID 10 MIN RAPID TEST … in human venous whole blood (sodium heparin, potassium EDTA, and sodium citrate), serum, and plasma (sodium heparin, potassium EDTA, and sodium citrate), and, by laboratories certified …
Coronavirus (COVID-19) Update: Daily Roundup October 1, 2020
… Today, the FDA revised its Emergency Use Authorization ( EUA ) to reflect changes in the distribution and allocation … Veklury (remdesivir). More information about the revised EUA can be found here . The FDA has issued a warning letter … Vitamin D with Chondroitin & Oleic”, “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid …
Sethi Laboratories - 611628 - 04/06/2021
… May 29, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § … SARS-CoV-2 in venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. However, this EUA does not authorize the sale of the Healgen COVID-19 …
AkivaMed Inc. - 609211 - 07/23/2020
… May 29, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § … in human venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. However, this EUA does not authorize the sale of the COVID-19 IgG/IgM Rapid …
Sonrisa Family Dental dba www.mycovidtest19.com - 607748 - 06/15/2020
… 12, 2020 FDA re-issued an Emergency Use Authorization (EUA) issued on April 1, 2020, pursuant to section 564 of the … and IgG antibodies against SARS-CoV-2, in serum, plasma (EDTA or citrate), or venipuncture whole blood from … of COVID-19 by their healthcare provider. However, this EUA does not authorize the sale of the qSARS-CoV-2 IgG/IgM …
Physician 360, Inc. - 604202 - 10/05/2020
… June 4, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § … plasma, and venous whole blood (sodium heparin, potassium EDTA, and sodium citrate). However, this EUA does not authorize the sale of the RightSign COVID-19 …
Zika EUA Table 1
… Molecular Zika Virus (ZIKV) Emergency Use Authorization (EUA) Assays - Performance Characteristics EUA Holder Assay … RealStar Zika Virus RT- PCR Kit U.S. May 13, 2016 Serum EDTA Plasma Urine Proprietary (S) 251.6 GEQ/mL (U) 79.6 … VERSANT Zika RNA 1.0 Assay (kPCR) Kit July 29, 2016 Serum EDTA plasma Urine Proprietary (S), (P) 721 GCE/mL (U) 1081 …
EUA Abbott Letter of Authorization
… EUA Abbott Letter of Authorization …
EUA Diasorin igg Letter Authorization
… EUA Diasorin igg Letter Authorization …
Abbott Lab EUA IFU-ARCHITECT
… Abbott Lab EUA IFU-ARCHITECT …
EUA Euroimmun-Igcurve Letter of Authorization
… EUA Euroimmun-Igcurve Letter of Authorization …
EUA Diasorin-igg Factsheet for Healthcare Providers
… EUA Diasorin-igg Factsheet for Healthcare Providers …
T-Detect COVID Test - EUA Summary
… EMERGENCY USE AUTHORIZATION (EUA) SUMMARY T-Detect COVID Test Adaptive Biotechnologies … using di-potassium ethylenediaminetetraacetic acid (K2 EDTA) as an anticoagulant. The T-Detect COVID Test is … Venous whole blood should be collected into a 10mL K2-EDTA vacutainer tube and shipped to the testing site at …
Amazon MultiTar EUA Summary
… 1 Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test EUA Summary: December 17, 2021 EMERGENCY USE AUTHORIZATION (EUA) OF THE AMAZON MULTI-TARGET SARS-CoV-2 REAL-TIME RT-PCR … RNAseP R Primer RNAseP Probe Probe HEX BHQ-1 TE: Tris-EDTA buffer Table 5. Consumables used to perform the Amazon …
EUA Diasorin-igg Information for Use
… (sodium heparin, lithium hepari n, an d p o t ass iu m EDTA) . The LIAISON® SARS-CoV-2 S1/S2 IgG is i n tended for … approved; • This test has been authorized by FDA under an EUA for use by l aboratories certif ied un der th e C l i n i … [DIL|SPE] One (1) vial. BSA, phosphate buffer, detergent, EDTA, 0.2% ProClin® 300, sheep serum, preservatives. …
Babson Diagnostics aC19G1 - EUA Summary
… Babson Diagnostics aC19G1 - EUA Summary …
Amazon Multi TDTC EUA Summary
… 1 Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test EUA Summary: January 26, 2022 EMERGENCY USE AUTHORIZATION (EUA) OF THE AMAZON MULTI-TARGET SARS-CoV-2 REAL-TIME RT-PCR … RNAseP R Primer RNAseP Probe Probe HEX BHQ-1 TE: Tris-EDTA buffer Table 6. Consumables used to perform the Amazon …
EUA Diasorin IGG LIAISON SARS-CoV-2 S1/S2 IgG
… EUA Diasorin IGG LIAISON SARS-CoV-2 S1/S2 IgG …
Helix SARS-CoV-2 Test - EUA Summary
… 1 Helix SARS-CoV-2 Test EUA Summary - July 14, 2022 EMERGENCY USE AUTHORIZATION (EUA) SUMMARY HELIX SARS-CoV-2 TEST For in vitro Diagnostic … UltraPlex 1 Step ToughMix QuantaBio 95166-01K Tris-Borate-EDTA Fisher Scientific BP2430-1 Saline, 0.85%, 1 L Hardy …
Vibrant COVID-19 Ab Assay - EUA Summary
… COVID-19 Ab Kit 1 ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY VIBRANT COVID-19 AB ASSAY ((VIBRANT AMERICA … Sample Diluent Contains BSA, PEG 600, 6-aminocaproic acid, EDTA and bovine gamma globulin in PBS C901222 COVID-19 IgG … 25 mg/ dL Vibrant America Labs Vibrant COVID-19 Ab Kit 9 EDTA 12.5 mg/ mL Acetaminophen 50 mg/ mL Ibuprofen 50 mg/ mL …
EUA Cobasliat Covid Flu-RSV IFU
… EUA Cobasliat Covid Flu-RSV IFU …